Ultrasound-Guided Dry Needling vs PRP for Refractory Lateral Epicondylitis

NCT07002879 | Completed

• 1 other identifier: İ07-436-22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, randomized, prospective study was conducted between January 2022 and September 2023 with ethics committee approval. Adults aged 18-65 with a clinical diagnosis of lateral epicondylitis-characterized by lateral elbow pain exacerbated by resisted wrist or middle finger extension-and who had not responded to at least six weeks of conservative treatment were included. Exclusion criteria included cervical disc disease, nerve entrapment, arthrosis, uncontrolled metabolic disorders, bleeding disorders, prior elbow surgery or injection, pregnancy, cognitive impairment, or compromised skin at the injection site. A G\*Power sample size calculation determined that at least 50 patients were needed. Participants were randomly assigned to two groups: 25 received ultrasound-guided dry needling and 25 received platelet-rich plasma (PRP) injections. All participants gave informed consent, and the study adhered to the Declaration of Helsinki. Baseline demographic and clinical data were collected, and the diagnosis was confirmed using Mills, Maudsley, and Thomsen tests, along with grip-strength assessment. Pain and function were evaluated using the PRTEE, Visual Analog Scale (VAS), and QuickDASH questionnaires at baseline, and at 1, 3, and 6 months post-treatment. Ultrasound imaging was used to identify tendinopathic changes. Local anesthesia was administered with 2 mL of prilocaine. In the dry needling group, an 18-gauge needle was used to fenestrate the tendon with 40-50 passes in a "peppering" motion under continuous ultrasound guidance. In the PRP group, 15 mL of blood was drawn, centrifuged, and approximately 2 mL of PRP was injected into the lesion under ultrasound guidance. After the procedure, patients were advised to apply ice, perform passive stretching, avoid lifting heavy objects, and refrain from NSAID use for two weeks. Gradual return to normal activities was encouraged thereafter to restore full elbow function.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (3)

• visual analog scale

  1-3-6 months

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire

  1-3-6 months

• Patient-Rated Tennis Elbow Evaluation

  1-3-6 months

Study Arms (2)

dry needle

ACTIVE COMPARATOR

An 18-gauge needle was first used to fenestrate the common extensor tendon and lateral periosteum. Once adequate anesthesia was confirmed, an 18-gauge needle was inserted along the tendon's longitudinal axis (without exiting the skin) and advanced in a "peppering" motion 40 to 50 passes from superficial to deep layers over approximately two minutes.

Procedure: dry needle

platelet rich plasma injection

ACTIVE COMPARATOR

A 15 mL peripheral blood sample was drawn and centrifuged at 3 000 rpm for 3 minutes. Approximately 2 mL of PRP was aspirated directly from the buffy coat and injected into the epicondylar region under ultrasound guidance.

Procedure: Platelet Rich Plasma

Interventions

dry needle PROCEDURE

An 18-gauge needle was first used to fenestrate the common extensor tendon and lateral periosteum. Once adequate anesthesia was confirmed, an 18-gauge needle was inserted along the tendon's longitudinal axis (without exiting the skin) and advanced in a "peppering" motion 40 to 50 passes from superficial to deep layers over approximately two minutes

dry needle

Platelet Rich Plasma PROCEDURE

A 15 mL peripheral blood sample was drawn and centrifuged at 3 000 rpm for 3 minutes. Approximately 2 mL of PRP was aspirated directly from the buffy coat and injected into the epicondylar region under ultrasound guidance.

platelet rich plasma injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ankara University

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 4, 2025
• Study Start: January 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 4, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)